Small/Large BowelNCT02560064
Length of Small Bowel. How Can Standardise Measurement and Why?
An observational study of Small/Large Bowel, run by Inonu University.
Trial summary
Measurement of the small bowel length studied by anatomists, surgeons and radiologists. Results were highly different among these series. Technical and mechanical factors have major effects on measures. Investigators decided to reach a standardization for the measurement of small bowel length. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Small/Large Bowel
- What is being tested?
- Laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Power analyse was done. Study include at least 44 patients.
Who may be able to join
- Candidate for abdominal surgery
Who cannot join
- Inflammatory bowel disease
- History of intraabdominal surgery
- peritonitis
Trial locations and contacts
No sites are listed yet.
About this study
Measurement of the small bowel length studied by anatomists, surgeons and radiologists. Results were highly different among these series. Technical and mechanical factors have major effects on measures. Investigators decided to reach a standardization for the measurement of small bowel length.
Read the detailed description
Small bowel length will be measure in patients undergoing intraabdominal surgery. This will be establish by two surgeon from Treitz ligament to ileocecal valve two, consecutively. For measurement, a tape will place to antimesenteric, mesenteric border and the midline between these two sides.
Exclusion criteria include patients with inflammatory bowel disease, peritonitis, prior abdominal surgery.
Demographic data, patients clinical details and small bowel length will be recorded.
- Conditions
- Small/Large Bowel
- Being tested
- Laparotomy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparotomyProcedure or surgery
Small bowel length will measure in laparotomy, regardless of indication.
| Study group | Role | What they receive |
|---|---|---|
| laparotomy and small bowel length | measurement of small bowel length in laparotomies Receives: Procedure: Laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Small Bowel. How Can Standardise Measurement and Why?
Measured: postop 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small/Large BowelStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Servet Karagül, Inonu University
- Investigators
- Cuneyt Kayaalp, Study director, Inonu University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560064
- Sponsor's protocol ID
- 2015/114
- Status last verified
- Sep 2015
- First submitted
- 16 Sep 2015
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Length of Small Bowel. How Can Standardise Measurement and Why?
- ClinicalTrials.gov ID
- NCT02560064
- Acronym / sponsor ID
- 2015/114
- Conditions
- Small/Large Bowel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measurement of the small bowel length studied by anatomists, surgeons and radiologists. Results were highly different among these series. Technical and mechanical factors have major effects on measures. Investigators decided to reach a standardization for the measurement of small bowel length.
Detailed description
Small bowel length will be measure in patients undergoing intraabdominal surgery. This will be establish by two surgeon from Treitz ligament to ileocecal valve two, consecutively. For measurement, a tape will place to antimesenteric, mesenteric border and the midline between these two sides.
Exclusion criteria include patients with inflammatory bowel disease, peritonitis, prior abdominal surgery.
Demographic data, patients clinical details and small bowel length will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laparotomy and small bowel length | – | Procedure: Laparotomymeasurement of small bowel length in laparotomies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Power analyse was done. Study include at least 44 patients.
Key inclusion criteria (1 listed)
- Candidate for abdominal surgery
Key exclusion criteria (3 listed)
- Inflammatory bowel disease
- History of intraabdominal surgery
- peritonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparotomySmall bowel length will measure in laparotomy, regardless of indication. | Procedure or surgery | laparotomy and small bowel length |
Primary outcome
Length of Small Bowel. How Can Standardise Measurement and Why?
Time frame: postop 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cuneyt Kayaalp study director
Inonu University, Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Small/Large Bowel, run by Inonu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Servet Karagul (905334779255, servetkaragul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Small Bowel. How Can Standardise Measurement and Why? (time frame: postop 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.